Home NDC 62175-382 Tacrolimus
Product NDC 62175-382
11-digit product format 621750382
Labeler code 62175
Product ID 62175-382_3a86a36e-029d-fded-1f9c-79177d3aaab6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tacrolimus
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler Kremers Urban Pharmaceuticals Inc.
Application ANDA090802
Marketing category ANDA
Marketing start 2015-07-30
Marketing end 0000-00-00
Substance TACROLIMUS
Active strength 5 mg/1
Pharmacologic classes Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 42 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 62175-382-37 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 62175-382-37 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 62175-382-37 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 62175-382-37 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 62175-382-37 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 62175-382-37 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 62175-382-37 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 62175-382-37 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 62175-382-37 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 62175-382-37 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 62175-382-37 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 62175-382-37 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 62175-382-37 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 62175-382-37 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 62175-382-37 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 62175-382-37 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 62175-382-37 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 62175-382-37 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 62175-382-37 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 62175-382-37 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 62175-382-37 9bebd1f3094a…5416666fcb17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090802-001 TACROLIMUS TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2012-09-28 A090802-002 TACROLIMUS TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2012-09-28 A090802-003 TACROLIMUS TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2012-09-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 126 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A090802-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2012-09-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090802-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2012-09-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090802-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2012-09-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090802-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2012-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090802-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2012-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090802-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2012-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090802-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2012-09-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090802-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2012-09-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090802-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2012-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090802-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2012-09-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090802-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2012-09-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090802-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2012-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090802-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2012-09-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090802-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2012-09-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090802-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2012-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090802-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2012-09-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090802-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2012-09-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090802-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2012-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090802-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2012-09-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090802-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2012-09-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090802-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2012-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090802-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2012-09-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090802-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2012-09-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090802-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2012-09-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090802-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2012-09-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090802-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2012-09-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090802-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2012-09-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090802-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2012-09-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090802-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2012-09-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090802-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2012-09-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090802-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2012-09-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090802-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2012-09-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090802-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2012-09-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090802-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2012-09-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090802-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2012-09-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090802-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2012-09-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090802-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2012-09-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090802-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2012-09-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090802-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2012-09-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090802-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2012-09-28 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TACROLIMUS ACTIVE INGREDIENT WM0HAQ4WNM TACROLIMUS CAPSULE, GELATIN COATED [KREMERS URBAN PHARMACEUTICALS INC.] 9 TACROLIMUS ANHYDROUS ACTIVE MOIETY Y5L2157C4J TACROLIMUS CAPSULE, GELATIN COATED [KREMERS URBAN PHARMACEUTICALS INC.] 9 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK TACROLIMUS CAPSULE, GELATIN COATED [KREMERS URBAN PHARMACEUTICALS INC.] 9 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 TACROLIMUS CAPSULE, GELATIN COATED [KREMERS URBAN PHARMACEUTICALS INC.] 9 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT TACROLIMUS CAPSULE, GELATIN COATED [KREMERS URBAN PHARMACEUTICALS INC.] 9 GELATIN INACTIVE INGREDIENT 2G86QN327L TACROLIMUS CAPSULE, GELATIN COATED [KREMERS URBAN PHARMACEUTICALS INC.] 9 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W TACROLIMUS CAPSULE, GELATIN COATED [KREMERS URBAN PHARMACEUTICALS INC.] 9 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 TACROLIMUS CAPSULE, GELATIN COATED [KREMERS URBAN PHARMACEUTICALS INC.] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TACROLIMUS CAPSULE, GELATIN COATED [KREMERS URBAN PHARMACEUTICALS INC.] 9 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TACROLIMUS CAPSULE, GELATIN COATED [KREMERS URBAN PHARMACEUTICALS INC.] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62175-382 TACROLIMUS CAPSULE, GELATIN COATED [KREMERS URBAN PHARMACEUTICALS INC.] 9 Legacy NDC 20150730_468deb25-1661-5a4e-a6e8-bc5088ac5977.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.